Bharat Biotech’s Covaxin Approved For Trials on Children Above 12; Covishield Trials To Be Conducted on Adults

The national drugs regulator DCGI on Sunday approved Bharat Biotech's Covaxin and Oxford-Serum's Covishield, for restricted emergency use in the country, paving the way for a massive inoculation drive.

New Delhi: The Drugs Controller General of India (DCGI) on Monday gave permission to the indigenously developed coronavirus vaccine ‘Covaxin’ of Bharat Biotech to conduct trials on children above the age of 12 years.

The national drugs regulator DCGI on Sunday approved Bharat Biotech’s Covaxin and Oxford-Serum’s Covishield, for restricted emergency use in the country, paving the way for a massive inoculation drive.

The DCGI granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

“Serum and Bharat Biotech vaccines have to be administered in two doses,” Somani said, adding these vaccines have to be stored at 2-8 C.

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Meanwhile, Oxford’s COVID-19 vaccine Covishield has been approved for trials on people above the age of 18. Covishield is being manufactured in India by the Pune-based Serum Institute of India, the world’s largest vaccine manufacturer, in a tie up with AstraZeneca.

SII was granted permission to conduct Phase-2/3 clinical trials on 1,600 participants within the country. “The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent,” DCGI VG Somani said.

On Covaxin, Somani said, “Bharat Biotech has developed a Whole Virion Inactivated Coronavirus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country and globally. The clinical trial ongoing within the country by the firm will continue.”